Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

By David Brühlmann - CMC Development Leader, Bioprocess Expert, Business StrategistScienceLife Sciences
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Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders episodes

  • 274: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 2

    Building a cell therapy company is hard. Building a genetically engineered iPSC therapy for the brain, on a preclinical budget, is one of the hardest translational problems in biotech. Every experiment has to move the program closer to an IND, or it's motion without progress.

    That's the operating constraint Bilal Fares faces as CEO and co-founder of AzureCell, the University of Geneva spin-off engineering neuroprotective iPSC neurons for Parkinson's disease. In Part 2, he walks through how his team decides what to build, where AI and synthetic biology genuinely accelerate a CMC roadmap, and the four founder lessons he wishes he'd internalized earlier, including his conviction that scientists who use AI will replace those who don't.

    Topics discussed include:

    • Strategies for prioritizing experiments and narrowing focus with limited resources (03:33)
    • How business opportunity validation programs helped define a product roadmap (04:08)
    • Integrating AI and synthetic biology into research programs—and where these tools do, and don’t, accelerate development (05:07)
    • Building a cell therapy platform for personalized approaches in neurological diseases beyond Parkinson’s (06:38)
    • Lessons learned in biotech leadership and why tackling big problems matters (08:08)
    • Key advice for aspiring biotech entrepreneurs: kill your own solutions quickly, and learn from others (09:27)
    • The importance of having a strong team and how a powerful mission attracts top talent (12:21)
    • AzureCell’s near-term plans and future goals, including upcoming fundraising and R&D milestones (13:30)

    Smart insight: What separates successful biotech ventures from the rest? According to Bilal Fares, it is not just technical skill but mindset. First, choose a problem large enough to be worth the struggle. Second, try to “kill your solution as fast as possible”—engage experts, enter competitions, and seek brutal feedback early so you can pivot, improve, or abandon as needed. And finally, plan with the end (approval, patients, impact) always in sight.

    If you enjoyed this, check out these episodes on cell therapy, where engineered cells can survive and do more than replace what's lost: Michael Rome's investor lens rounds it out for founders facing the same funding realities.

    • Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo
    • Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
    • Episodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez
    • Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome

    Connect with Bilal Fares:
    LinkedIn: www.linkedin.com/in/b-fares
    AzureCell website: www.azurecell.co
    Email: [email protected]

    Support the show

    17 min
  • 273: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 1

    Transplant iPSC-derived neurons into a Parkinson's brain and 97% die before they can restore function. Of the 3% that survive, most face the same pathogenic environment that killed the original neurons. This is the compounded biology and CMC problem defining CNS cell therapy today.

    Bilal Fares, neuroscience entrepreneur and co-founder of AzureCell, is translating a University of Geneva discovery into a genetically engineered iPSC platform built to solve it: neurons that don't just replace what Parkinson's destroyed, but survive the fire that destroyed them.

    Topics discussed:

    • Why Bilal believes cell therapy is the future of medicine for brain diseases, and the limitations of other approaches (03:06)
    • Bilal’s personal story and the events that guided his commitment to Parkinson’s research and entrepreneurship (04:03)
    • How cell therapy might move beyond simply replacing lost neurons—using engineered cells to produce therapeutics directly in the brain (09:05)
    • The neuroprotective technology AzureCell is developing, designed to shield transplanted neurons from Parkinson’s disease mechanisms (11:31)
    • The platform approach: combining stem cell technologies, genetic engineering, and allogeneic off-the-shelf cell banks (12:38)
    • Why the blood-brain barrier makes cell therapy a necessary approach for certain conditions (13:26)
    • The current status of Azure’s preclinical and manufacturing development, and their plans for clinical translation (14:31)
    • Why previous therapies for Parkinson’s have fallen short, and how cell therapy might sidestep these limitations (15:57)
    • The potential and challenges of using cell therapy for other brain diseases like Alzheimer’s (18:26)

    Smart insight: The next generation of CNS cell therapy isn't only about neuron replacement. Bilal's thesis reframes transplanted cells as engineered biological factories inside the brain: producing neuroprotective proteins, modulating disease mechanisms in real time, and eventually enabling preventative treatment as manufacturing costs fall and safety matures.

    If you enjoyed this, check out these episodes on cell therapy, where engineered cells can survive and do more than replace what's lost: Michael Rome's investor lens rounds it out for founders facing the same funding realities.

    • Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo
    • Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
    • Episodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez
    • Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome

    Connect with Bilal Fares:
    LinkedIn: www.linkedin.com/in/b-fares
    AzureCell website: www.azurecell.co
    Email: [email protected]

    Support the show

    21 min
  • 272: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 2

    How much of your research lives and dies on the bench? Not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle.

    Jan Hunik and Matt Baker from MosaMatrix discuss the practical challenges and lessons learned from spinning out a biomaterials company from academia. They explore the importance of quality standards in biotech startups, building a team with complementary skills, and the realities of developing reproducible 3D culture systems for modern research.

    Topics discussed:

    • The critical gap between invention and reliable biomaterial products (00:40)
    • Building company culture around quality standards from day one (02:45)
    • Balancing scientific curiosity and business direction as co-founders (03:51)
    • The impact of university partnerships on early-stage company development (06:02)
    • Funding challenges and strategies for sustaining a biotech startup (06:47)
    • Advice for scientists on addressing real market needs versus pushing technology (07:50)
    • The importance of listening to customers and investors to find product-market fit (09:19)
    • Vision for scaling technology and breaking even in the next two to three years (10:06)
    • New frontiers in engineering living materials and animal-free biomaterials (12:04)

    Smart insight: The MosaMatrix team believes good materials are key to unlocking advances in drug discovery, cellular agriculture, and engineered living materials. Their story is a testament to how integrating rigorous science, business discipline, and a razor focus on real-world needs can create the foundation for lasting innovation in biotech.

    If this conversation got you thinking about biomaterials, scale-out manufacturing, and what it takes to turn a chemistry breakthrough into a fundable company, these episodes explore the same ground from complementary angles.

    • Episodes 221 - 222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito
    • Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome
    • Episodes 265 - 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch
    • Episodes 223 - 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang

    Connect with Jan Hunik and Matt Baker:

    • Emails: [email protected] and [email protected]
    • Website: www.mosamatrix.com
    • LinkedIn Jan Hunik: www.linkedin.com/in/jan-hunik-0183734
    • LinkedIn Matt Baker: www.linkedin.com/in/matthew-baker-0abb981b

    Support the show

    16 min
  • 271: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 1

    What if the real obstacle in 3D cell culture and tissue engineering isn't the cells, but the very ground they grow on?

    For years, cell culture has relied on flat plastic and passive scaffolds. But biology doesn't happen on a petri dish—cells live in three dimensions, surrounded by a dynamic environment that talks back, adapts, and shapes development in ways static gels simply cannot.

    That's the premise behind MosaMatrix, a novel hydrogel platform designed to transform how we grow cells, engineer tissues, and screen new drugs created by CEO Jan Hunik and CTO Matt Baker.

    Topics discussed:

    • Why traditional flat, 2D cell culture misses the biological mark and what a responsive cell environment really looks like (00:27)
    • The origins of MosaMatrix and the realization that new, adaptive hydrogels were needed for dynamic cell culture (04:45)
    • What makes the MosaMatrix hydrogel different—and why passive scaffolds fall short (06:12)
    • Mechanical and biological characteristics that define hydrogel performance, from stiffness to stress relaxation (07:48)
    • The company's pivot from 3D tissue printing to focusing on high-throughput 3D cell culture for drug discovery (08:42)
    • Advantages of a non-animal-derived, reproducible matrix for research and industry (10:20)
    • Strategies for obtaining real-world customer feedback and working in consortia with academia and industry partners (11:51)
    • Key hurdles in quality control, reproducibility, and measuring success in the emerging field (16:05)
    • Challenges with standardizing organoids and the move to smaller, more automatable culture systems (17:50)
    • The impact of automation and data consistency for scaling up 3D cell culture (18:14)

    Smart insight: MosaMatrix validates its hydrogel not through internal R&D alone, but through direct collaboration with academic and industry partners — testing performance across cell types and culture media. This includes a ~50-company consortium building next-gen 3D cell culture tools and a new consortium improving kidney dialysis with living human cells. The partnerships surface real variables, like how much culture media composition affects results, that continually shape product development.

    If this conversation got you thinking about biomaterials, scale-out manufacturing, and what it takes to turn a chemistry breakthrough into a fundable company, these episodes explore the same ground from complementary angles.

    • Episodes 221 - 222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito
    • Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome
    • Episodes 265 - 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch
    • Episodes 223 - 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang

    Connect with Jan Hunik and Matt Baker:

    • Emails: [email protected] and [email protected]
    • Website: www.mosamatrix.com
    • LinkedIn Jan Hunik: www.linkedin.com/in/jan-hunik-0183734
    • LinkedIn Matt Baker: www.linkedin.com/in/matthew-baker-0abb981b

    Support the show

    21 min
  • 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 2

    In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors.

    In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for the platform.

    Topics discussed:

    • Why glioblastoma is the right Phase I indication: infiltrative growth, immunosuppression, and STING pathway deficiencies that make GBM uniquely suited to the platform (02:43)
    • The surgical workflow: intracavity MSC delivery during tumor resection, oral 5-FC administration, and how engineered cells act as local bioreactors in the resection cavity (04:05)
    • Mechanisms by which engineered MSCs target heterogeneous and invasive tumors through shared vulnerabilities rather than antigen recognition (05:58)
    • Overcoming immune rejection with allogeneic therapies and the unique immunological profile of MSCs (07:32)
    • Manufacturing and scale-up: addressing donor variability, GMP production, and building a reproducible process (09:16)
    • Why GMP manufacturing should be designed in from the earliest stages of research (10:50)
    • Beyond glioblastoma: expanding the platform to other solid tumors, regenerative medicine, and chronic inflammatory disease (11:27)
    • Strategies for international trial expansion and partnerships beyond Singapore (12:41)
    • Reframing MSCs from stem cell therapy to programmable delivery platform: the MSC 2.0 thesis (14:10)

    Smart insight: The shift Jun Yung articulates is from treating stem cells as the therapy to treating them as programmable therapeutic vehicles. Once you can reliably engineer, manufacture, and preserve their function, the limitation is no longer what the cell naturally does. It becomes what biology you can encode into it. Glioblastoma is the proving ground, and the platform's reach extends to liver cancers, sarcomas, peritoneal malignancies, and chronic inflammatory disease.

    These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies:

    • Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
    • Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
    • Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
    • Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster

    Connect with Jun Yung Woo:

    LinkedIn: www.linkedin.com/in/junyungwoo

    AGEM Bio website: www.agem.bio

    Email: [email protected]

    Support the show

    17 min
  • 269: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 1

    What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do For years, mesenchymal stem cells (MSCs) have turned heads for their ability to home in on damaged tissue, yet their clinical utility has lagged behind the hype. What would it take to transform MSCs from passive healers into precision vehicles for next-generation cancer treatment?

    This week, David Brühlmann sits down with Jun Yung Woo, Co-Founder of AGEM Bio, who’s devoted nearly two decades to decoding and reimagining the potential of MSCs. From engineering stress-resilient cells to pioneering dual-payload therapeutic platforms, Jun Yung Woo bridges fundamental biology and real-world clinical translation.

    Topics discussed:

    • The case for understanding cell biology before focusing on process scale-up in bioprocessing (02:38)
    • Jun Yung Woo's personal and scientific journey toward developing engineered MSC therapeutics (04:36)
    • How MSCs sense their environment and exert therapeutic effects via secreted factors, rather than tissue replacement (08:28)
    • Key differences between MSC therapies and immune cell therapies like CAR T cells (10:35)
    • Overview of non-viral engineering platforms, and the importance of intracellular trafficking for modifying MSCs (12:23)
    • Design of AGEM Bio's dual-payload MSC product (cytosine deaminase and interferon beta) to induce highly localized tumor stress and immune activation (14:10)
    • Strategies for controlling MSC targeting and minimizing off-target effects, including the use of prodrug activation and localized cell delivery (17:23)
    • Study results from treating companion animals with engineered MSCs, and observations of tumor regression and possible signs of immune memory (20:29)
    • Open questions about the durability of antitumor responses and future directions for clinical research (22:34)

    Smart insight: Jun Yung Woo challenges the rush toward bioprocess scale-up, arguing that a deeper understanding of cellular biology should come before manufacturing cells at scale. This episode explores how scaling the wrong biology can derail entire therapeutic platforms—and why aligning process development with cellular function may be critical for clinical success.

    These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies:

    • Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
    • Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
    • Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
    • Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster

    Connect with Jun Yung Woo:

    LinkedIn: www.linkedin.com/in/junyungwoo

    AGEM Bio website: www.agem.bio

    Email: [email protected]

    Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here

    Support the show

    27 min
  • 268: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 2

    Why does life-saving insulin cost hundreds of dollars a month for patients, when manufacturing costs are just a fraction of that price? What if the nonprofit model could change everything for affordable access?

    In the pharmaceutical industry, affordability and access remain two of the biggest hurdles for patients, especially when the economics of essential medicines seem stacked against them.

    Eric Moyal, founder of Project Insulin, is rewriting the rules of biosimilar development. Coming from a fundraising and nonprofit background rather than the pharma inside track, Eric built Project Insulin not to chase profits, but to deliver an essential therapy at a price real people can afford.

    Topics covered:

    • Key differences between nonprofit and for-profit models in biotech, especially around fundraising, incentives, and revenue (00:02)
    • The intricate balance between development costs, operating expenses, and setting an affordable price point (00:06)
    • Innovative distribution models to eliminate price inflation by middlemen, including direct-to-patient and clinic partnerships (00:08)
    • Major roadblocks in reinventing drug distribution and the importance of building the right partnerships early on (00:10)
    • Advice for founders and scientists exploring solutions to drug affordability, including corporate structure, fundraising, and perseverance (00:12)
    • Lessons learned after five years building Project Insulin, emphasizing the value of assembling the right team and listening to feedback (00:13)
    • Realistic expectations for Project Insulin’s next five years and the primary goals on the horizon (00:16)
    • The broader need for affordable generic drugs and the broken promise of the current patent system (00:17)
    • How to connect with Project Insulin and support its mission (00:18)

    Smart insight: Generic medicines should be affordable. Ensuring low-cost, accessible generics is essential to restoring the original balance between pharmaceutical innovation and public access, and it requires collective effort beyond any single player.

    If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams:

    • Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
    • Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
    • Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa

    Connect with Eric Moyal:

    • Email: [email protected]
    • Website: www.projectinsulin.org
    • Instagram: www.instagram.com/projectinsulin
    • LinkedIn: www.linkedin.com/company/82500193
    • TikTok: www.tiktok.com/@project.insulin
    • YouTube: www.youtube.com/@ProjectInsulin

    Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.

    Support the show

    21 min
  • 267: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 1

    Insulin was first discovered over a century ago—yet in the United States, 1 in 5 insulin-dependent patients still ration their lifesaving supply. Why is a molecule so essential, and so well understood, still so out of reach for so many?

    Eric Moyal, founder of Project Insulin, decided to challenge not just the science, but the business model itself. With a background in nonprofit fundraising—not drug development—he’s building a biosimilar insulin glargine and promising to sell it directly to patients at cost, insurance or not.

    Topics discussed include:

    • The origins of the insulin affordability crisis and the impact of profit-driven healthcare systems (04:27)
    • How over a million Americans are forced to ration their insulin every month, and the broader impact on patients’ (lives 06:37)
    • The advantages and challenges of approaching drug development with a background outside of biotech (08:37)
    • The fundraising-focused strategy for overcoming scientific and technical hurdles in developing biosimilar insulin (09:17)
    • Technical details on Project Insulin’s development process, including selection of CDMOs, importance of analytical data, and process challenges like reverse-phase cleaving and crystallization (11:16)
    • The impact of recent FDA regulatory changes on the development and approval pathway for biosimilars in the U.S. (15:45)

    Smart insight: A nonprofit approach to essential medicines could reshape the future for patients who depend on them. By removing shareholder expectations and focusing on affordability and access, leaders like Eric Moyal are proving new paths are possible—not through incremental science alone, but through bold re-imaginings of how science serves the public.

    If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams:

    • Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
    • Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
    • Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa

    Connect with Eric Moyal:

    • Email: [email protected]
    • Website: www.projectinsulin.org
    • Instagram: www.instagram.com/projectinsulin
    • LinkedIn: www.linkedin.com/company/82500193
    • TikTok: www.tiktok.com/@project.insulin
    • YouTube: www.youtube.com/@ProjectInsulin

    Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.

    Support the show

    19 min
  • 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 2

    The cell and gene therapy industry faces massive hurdles—cost, scalability, and the need for highly skilled operators have historically limited the reach of these transformative treatments. advanced therapy medicinal products manufacturing innovation is urgently needed to overcome these challenges and unlock broader global access.

    Farlan Veraitch, founder and Chief Scientific Officer at Ori Biotech, is leading the way in reimagining manufacturing platforms using automation, modularity, and digital transformation. His vision is redefining how cell and gene therapies are produced—from research labs to point-of-care hospital settings.

    What’s inside:

    • The use and adaptation of the paper pull tab sterile connection system—miniaturized and multiplexed—to ensure reliable material transfer in the manufacturing process (06:36)
    • How modular and stackable system design supports scale-up and scale-out, increasing manufacturing capacity and flexibility (09:17)
    • Full digitization of the Ori platform, including setting up digital twins, integrating sample prep automation, and capturing data for QA/QC in real time (10:11)
    • Deskilling bioprocess operations, reducing the need for highly trained cell culture staff, and enabling broader use in both centralized facilities and hospitals (14:02)
    • The logistical benefits of separating material prep (like buffer and virus formulation) from the manufacturing site to streamline point-of-care applications (15:39)
    • Farlan’s vision for an accessible, profitable, globally distributed manufacturing platform to support new treatment pipelines (17:14)
    • Driving down cost and improving scalability as key challenges to unlocking the potential of cell and gene therapies (18:49)

    Strategic insight:

    The cell and gene therapy field needs to lower manufacturing costs and increase production. Focused, practical approaches are required to make these life-changing therapies more efficient, scalable, and accessible to more patients around the world.

    Listen for practical perspectives on automation, digital tools, manufacturing infrastructure, and the future possibilities for decentralized, scalable cell and gene therapy production.

    Connect with Farlan Veraitch:

    LinkedIn: www.linkedin.com/in/farlan-singh-veraitch-a677112

    Email: [email protected]

    Ori Biotech: www.oribiotech.com

    Next step:

    Need fast CMC guidance? → Get rapid CMC decision support here

    Support the show

    22 min
  • 265: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 1

    What if the simple act of opening an incubator could undermine the consistency of your cell therapy manufacturing process? Unlike traditional biologics, the moment cells leave their incubator, subtle shifts in temperature, CO₂, and pH can spiral into mission-critical variability, jeopardizing everything from product yield to therapeutic potency.

    This episode features Farlan Veraitch, founder and Chief Scientific Officer of Ori Biotech. Trained at UCL’s Department of Biochemical Engineering, Farlan blends a bioprocess engineer’s mindset with hands-on experience scaling monoclonal antibodies, before pioneering the first-ever automation platform for embryonic stem cell culture. His drive for eliminating variability and designing systems that scale seamlessly from bench to bedside has informed ORI’s approach to modular cell therapy manufacturing.

    What you’ll hear in this episode:

    • The importance of controlling pH, temperature, and shear forces in cell therapy manufacturing (00:36)
    • Lessons learned from scaling monoclonal antibody production and its impact on biotech business models (05:23)
    • The unique sources of variability in primary and stem cells, and why automation is essential (11:16)
    • Strategies to minimize human-induced variability in sensitive cell cultures (12:59)
    • How exposure to ambient oxygen and CO₂ during manual processing affects cell viability (14:13)
    • The logic behind Ori Biotech’s modular design to solve environmental control issues (19:04)

    Strategic insight:

    As cell and gene therapies push boundaries, manufacturing must keep pace with exponentially tighter requirements. Farlan’s journey highlights a universal lesson for scientists and engineers: process control is not just a technicality, but a necessity for reproducible, scalable, and commercially viable therapies.

    If you’re grappling with process variability or looking for fresh strategies in cell and gene therapy development, this episode offers an inside view from a scientist who’s worked at the intersection of bioprocess, automation, and commercial translation.

    Connect with Farlan Veraitch:

    LinkedIn: www.linkedin.com/in/farlan-singh-veraitch-a677112

    Email: [email protected]

    Ori Biotech: www.oribiotech.com

    Next step:

    Need fast CMC guidance? → Get rapid CMC decision support here

    Support the show

    23 min

About Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

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The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and…

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